Kornimate/medical-research-clean huggingface dataset:
usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux.

Conditions: Urinary Tract Infection

Summary: randomized, prospective, multicenter study in order to assess the usefulness of antimicrobial prophylaxis in children with isolated vesico-ureteral reflux (grade iii or less).

a voiding cystourethrogram was performed for each child less than 3 years old with a first urinary tract infection. in case of vesico-ureteral reflux, a randomization was done between continuous antimicrobial prophylaxis with low dose of trimethoprim-sulfamethoxazole and no antibioprophylaxis. duration of follow up was 18 months.

Eligibility criteria:
inclusion criteria: * children less than 3 years old * first proved urinary tract infectionisolated vesico-ureteral reflux * parents have been fully informed and have given written informed consent to participate in the study exclusion criteria:

Keywords: urinary tract infection vesico-renal reflux child antimicrobial prophylaxis recurrence of urinary tract infection
clinical safety and efficacy of ct asphina 509 lenses

Conditions: Cataract

Summary: clinical safety and efficacy of ct asphina 509 iols after implantation


Eligibility criteria:
inclusion criteria: patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent; * patients of any gender * assured follow-up examinations * biometry measurement preferably compatible with the iolmaster evaluation; * iol implanted into the capsular bag with iol model ct asphina 409mp (uve material) in one eye with at least 12 months follow up at the time of the postop visit * patients who had uncomplicated (no peroperative complication) agedrelated cataract surgery in a healthy eye (beside clinically significant cataract) exclusion criteria: * • bcva not available preoperatively or better than 0.3 logmar pre-op * patients unable to meet the limitations of the protocol or likely of noncooperation during the trial * patients whose freedom is impaired by administrative or legal order * concurrent participation in another drug or device investigation
a prospective longitudinal study to identify biomarkers in children with hemangiomas

Conditions: Hemangioma

Summary: current treatment options for hemangiomas, such as propranolol, steroids and interferon, all have the potential for significantly harmful side effects. the purpose of this study is to identify potential biomarkers that can be used to design clinical trials and accelerate the delivery of new treatment alternatives to children with hemangiomas.

urine will be collected from children with hemangiomas and age-matched healthy controls at 2,4,6,9,12,18 and 24 months of age. children with hemangiomas will also have ultrasound examination performed at each visit.

Eligibility criteria:
inclusion criteria: * children with hemangioma * age ≤ 5 months * doppler ultrasound confirmed diagnosis of hemangioma to rule out presence of vascular malformation * age matched control ≤ 5 months (no hemangioma) exclusion criteria: * hemangioma treated prior to or during study period with laser, steroids, interferon, or propranolol, or any other drug or device intended to inhibit the growth of the hemangioma * known history of sickle cell anemia, thalassemia, or other hemoglobinopathy * hemangioma presented as fully formed at birth consistent with rapidly involuting or non-involuting congenital hemangioma * phaces syndrome- posterior fossa malformations, hemangioma, arterial anomalies, cardiac anomalies, eye abnormalities, sternal anomalies * parent/guardian unable to speak english to provide informed consent and no interpreter is present
testing a decision aid for women with urogenital prolapse

Conditions: Pelvic Organ Prolapse

Summary: development of a decision aid for women with urogenital prolapse followed by an intervention with use of the decision aid to investigate the effect on the perceived shared decision making in the clinical consultations. a protocol for a randomized controlled non blinded multicenter trial. a feasibility trial for the protocol.

objective : the objective is to develop a decision aid to increase successful patient involvement and increased health care professionals integration of preferences in the clinical consultations with women with urogenital prolapse. method: in the context of consultations an online app solution using a multicriterial analytic approach is developed and tested in order to support shared decision making (sdm). the decision aid is developed involving four national gynecological departments through participatory design. the decision aid is tested in a randomized, controlled multicenter trial in three hospital departments in the region of southern denmark. a feasibility trial for the protocol of a randomized controlled trial will decide for further approach in relations to testing the online app. in a larger scale in the randomized trial patients will either receive consultations as usual (controls) or consultations using the interface (if) in an app. the if is generated upon data from a patient survey regarding their preferences for treatment beforehand. effect measures are the perceived shared decision making within the consultation (sdm-q-9 ) and the patientperceived satisfaction with the decision (swd)

Eligibility criteria:
inclusion criteria: * urogenital prolaps symptoms * e boks exclusion criteria: * complicated pelvic organ prolapse which requires treatment other than dialogue, pessary, cystocele or rectocele surgery, physiotherapy or local hormones * physical status classification system (asa) score 3 or above * not able to understand danish without interpreter * recurrent pelvic organ prolapse

Keywords: shared decision making
coagulation disturbances in covid-19 septic patients

Conditions: Coagulation Disorder; COVID 19 Associated Coagulopathy; Sepsis; Septic Shock

Summary: objective of this study was to determine the relationship between cac and septic condition in covid-19 critically ill patients. data including age, sex, comorbidities, quick sequential organ failure assessment (qsofa) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (pct), c-reactive protein (crp), fibrinogen, d-dimer, sepsis-induced coagulopathy (sic) and disseminated intravascular coagulation (dic) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. primary outcome was to establish cac with sepsis; secondary outcome measure was incidence of cac in sepsis and septic shock in covid-19 critically ill patients.


Eligibility criteria:
inclusion criteria: * all adult critically ill patients tested positive for reverse transcriptase polymerase chain reaction (rt-pcr) of nasopharyngeal swabs to coronavirus 2 (sars-cov-2) * patienets admitted to the icu and presented with acute hypoxemic respirator failure exclusion criteria: * patients younger than 18, * immunodeficient patients, * patients with a history of malignancies, * patients who developed septic state before admission, * patients with a history of previous coagulopathy, liver and platelet disease.
technology and design innovation for school lunch

Conditions: Childhood Obesity

Summary: this study will evaluate an innovative school lunch intervention that is designed to increase school meal participation and improve dietary intake among middle and high school students.

improving dietary intake among low-income youth is critical to reducing obesity, and schools are arguably the most important system in which to intervene. in 2010, congress passed the healthy, hunger-free kids act to better align school meal standards with the dietary guidelines, making school meals a nutritious option for students. increasing participation in the school meal program, therefore, especially among low-income youth, has the potential to improve dietary intake among students and ultimately reduce childhood obesity. over three school years, the university of california (berkeley's school of public health and the division of agriculture and natural resources' nutrition policy institute) will evaluate an innovative, student-centered school-lunch intervention to increase school lunch participation and improve dietary intake among low-income middle and high school students. the project will be conducted in the san francisco unified school district (sfusd), a large and diverse urban district serving over 32,000 students (70% of total) eligible for free or reduced-price meals. the intervention, developed in partnership with the global design firm ideo, aims to promote healthier habits by leveraging principals of behavior economics. the intervention involves the following three components: 1) a smartphone application (smartmeal) that allows students to pre-order school lunches, receive nutrition information about school lunch options, and provide feedback about meals to food service staff, 2) distributed points of sale for school meals, achieved through the addition of mobile food carts and vending machines, and 3) a staff wellness curriculum that encourages staff to promote school meals and model healthful eating behaviors to students.

Eligibility criteria:
inclusion criteria: * all 7th-10th grade students at participating schools are eligible to participate in the student survey * all 6th-12th grade students who eat the school lunch are eligible to participate in plate waste data collection * all 7th-10th grade teachers are eligible to participate in the teacher survey exclusion criteria: * there are no exclusion criteria

Keywords: secondary schools school lunch plate waste
a study of du-176b in preventing blood clots after hip replacement surgery

Conditions: Thrombosis; Hip Replacement

Summary: this study is to assess if du176b is effective in prevention of blood clots following hip replacement surgery. the duration is 7-10 days of treatment and 30 and 60 day follow-up visits.


Eligibility criteria:
1. 18 years of age or older; male or female. 2. able to provide written informed consent. 3. must be scheduled for elective unilateral total hip replacement surgery. only primary surgeries accepted. 4. if female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the investigator and in accordance with local regulatory requirements.

Keywords: anti-coagulant hip replacement hip replacement surgery unilateral hip replacement surgery deepvein thrombosis venous thromboembolism pulmonary embolism prevention of blood clots
efficacy of daratumumab to overcome platelet transfusion refractoriness in patients with aplastic anemia

Conditions: Aplastic Anemia; Platelet Transfusion Refractoriness

Summary: this is a phase 1, prospective, single-arm, open-label study. the aim of this study is to evaluate the transfusion responses of platelet increment by using daratumumab among aplastic anemia patients with platelet transfusion refractoriness.


Eligibility criteria:
inclusion criteria: * diagnosis of aplastic anemia (aa) * dependent on platelet transfusions, characterized by either plt\<10×10\^9/l, or plt\<20×10\^9/l with bleeding events. * diagnosed with platelet transfusion refractoriness, characterized by corrected count increment (cci) \<7500/ul at 60 min, or cci \<4500/ul at 24 hrs. * male or female age ≥ 12 years * ecog performance status ≤2 * willing and able to comply with the requirements for this study and written informed consent. exclusion criteria: * the inherited bone marrow failure syndromes * the presence of hemolytic pnh clone * combination of either radiotherapy or chemotherapy for solid tumors in recent 3 years, excluding the local tumor diagnosed 1 year ago and cured by surgical resection. * cytopenia caused by other diseases, including liver cirrhosis, active rheumatic connective tissue disease, and persistence of infectious diseases, etc. * uncontrolled infection * hiv, hcv or hbv active infection * the presence of any of the following bleeding events: * gastrointestinal bleeding * respiratory tract hemorrhage * central nervous system bleeding * abnormal liver function: alt or ast \> 2 uln, or tbil \> 2 uln after treatment. * abnormal kidney function: creatinine clearance \< 30 ml/min * heart failure (nyha class iii or iv) * poorly controlled diabetes, characterized by fasting blood glucose \> 8.8mmol/l or post-meal blood glucose \> 11.1mmol/l after therapy with insulin or oral hypoglycemic agents * history of congestive heart failure, unstable angina pectoris, myocardial infarction, arterial or venous thrombosis * pregnant or breast-feeding patients * had a history of any psychiatric diseases, cerebrovascular disease or cognitive sequelae of head injury. * participation in another clinical trial within 4 weeks before the start of this trial * have an allergy to daratumumab or any other part of this medicine. * previously treated with daratumumab * previously treated with atg/alg within 4 months before the start of this trial * previously treated with the anti-cd20 monoclonal antibody within 2 months before the start of this trial * currently treated with tpo-ra except for a minimum of 4 weeks for washout before the start of this trial * patients considered to be ineligible for the study by the investigator for reasons other than above

Keywords: platelet transfusion refractoriness daratumumab
safety and efficacy of cdb-2914 in comparison to levonorgestrel for emergency contraception

Conditions: Contraception

Summary: the purpose of this study is to assess the safety and efficacy of cdb-2914 in comparison to levonorgestrel for preventing pregnancy up to 5 days after unprotected sexual intercourse.


Eligibility criteria:
inclusion criteria: * women 16 or older in uk(except northern ireland) sites, 17 years or more in northern ireland (uk) and 18 years or more in ireland and us * present within 120 hours of unprotected intercourse * regular menstrual cycles * no current use of hormonal contraception * willing to not use hormonal methods of contraception until study completion * at least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion * for women who present more than 72 hours after intercourse, decline the insertion of an intra uterine device for emergency contraception * able to provide informed consent * willing to abstain from further acts of unprotected intercourse until study completion exclusion criteria: * one or more acts of unprotected intercourse more than 120 hours * current or recent use of hormonal methods of contraception * currently pregnant or breastfeeding * tubal ligation or current use of iud * use of hormonal emergency contraception since last menstrual period * current use of iud * tubal ligation * partner with a vasectomy * unsure about the date of the last menstrual period * severe asthma insufficiently controlled by oral glucocorticoid * hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
temozolomide in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma

Conditions: Central Nervous System Tumors; Brain Tumor

Summary: rationale: drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well temozolomide works in treating patients with newly diagnosed anaplastic oligodendroglioma or mixed oligoastrocytoma.

objectives: * determine progression-free survival of patients with newly diagnosed anaplastic oligodendroglioma (ao) or mixed oligoastrocytoma (moa) treated with temozolomide. * determine the response rate in these patients. * assess the quality of life of patients with ao or moa treated with this regimen. outline: this is a parallel-group, multicenter study. patients are stratified according to disease type (anaplastic oligodendroglioma vs mixed oligoastrocytoma). patients receive oral temozolomide once daily on days 1-7 and 15-21. treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, before courses 1, 3, 5, and 7, every 3 months for the first year after completion of treatment, every 4 months for the second year, every 6 months for the third and fourth years, and once a year thereafter. after completion of study treatment, patients are followed periodically. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed anaplastic oligodendroglioma or mixed oligoastrocytoma meeting 1 of the following criteria: * bidimensionally measurable disease * evaluable disease * nonevaluable disease as demonstrated by gross total surgical resection * no immediate need for cranial irradiation patient characteristics: * karnofsky performance status 70-100% * life expectancy ≥ 12 weeks * absolute granulocyte count ≥ 1,500/mm³ * hemoglobin ≥ 10.0 g/dl * platelet count ≥ 100,000/mm³ * creatinine ≤ 1.5 times upper limit of normal (uln) * bilirubin ≤ 2.0 times uln * ast ≤ 3.0 times uln * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no infection requiring systemic antibiotics within the past 14 days * no other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer * no unrelated medical problems that would preclude study compliance prior concurrent therapy: * no prior chemotherapy for this malignancy * no prior radiotherapy to the brain * no surgery requiring general anesthesia \> 2 hours in duration within the past 10 days * no prior temozolomide * concurrent steroids allowed provided dose is stable or decreasing for at least 1 week prior to study entry

Keywords: adult anaplastic oligodendroglioma adult mixed glioma
robotic versus video-assisted lobectomy/segmentectomy for lung surgery

Conditions: Lung Diseases; Surgery

Summary: to compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (ral/s) with the video-assisted lobectomy/segmentectomy (val/s) for lung resection. video-assisted lobectomy/segmentectomy (val/s) for lung resection is divided into uniport group and multiple- port group.


Eligibility criteria:
inclusion criteria: 1. good cardio- pulmonary function to tolerate surgery; 2. minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy; exclusion criteria: 1. cardio- pulmonary function is not good enough to tolerate surgery; 2. huge tumor or extensive adhesion in thoracic cavity.

Keywords: robotic surgery vats uniport multiport
a study of an fgfr2/3 inhibitor (cgt4859) in patients with cholangiocarcinoma and other advanced solid tumors

Conditions: Intrahepatic Cholangiocarcinoma (Icc); Cholangiocarcinoma; Other Solid Tumors, Adult; FGFR2 Gene Fusion/Rearrangement; FGFR2 Gene Amplification; FGFR2 Gene Short Variants; FGFR3 Gene Fusion/Rearrangement; FGFR3 Gene Amplification; FGFR3 Gene Short Variants; FGFR2 Genetic Alterations; FGFR3 Genetic Alterations; Advanced Solid Tumors

Summary: this is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of cgt4859 in adult participants with intrahepatic cholangiocarcinoma (icca) or other advanced solid tumors with fgfr2 and/or fgfr3 genetic alternations.


Eligibility criteria:
key inclusion criteria: 1. histologically confirmed locally advanced, metastatic, and/or unresectable icca or other solid tumor with documented fgfr2/3 alteration in blood and/or tumor. 2. previously treated with, not appropriate for, or declined standard-of-care first-line treatment. 3. have measurable disease per recist v1.1. 4. eastern cooperative oncology group (ecog) performance status of 0-1. 5. have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits. 6. resolution of toxicities from prior therapy to ≤grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention. key exclusion criteria: 1. received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug. 2. major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug. 3. clinically significant corneal or retinal disorders or current evidence of retinal detachment. 4. received more than 2 prior fgfri therapies 5. active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.

Keywords: cholangiocarcinoma intrahepatic cholangiocarcinoma advanced solid tumors investigational drug phase 1 phase 2 fgfr2 fgfr3 fgfr2/3 first in human fgfr 2 genetic alterations fgfr3 genetic alterations
whole-body mri in suspected victims of abusive head trauma

Conditions: Shaken Baby Syndrome

Summary: the purpose: to pilot whole-body mri scanning in infants who are already getting brain mri for suspected child abuse research design: prospective, blinded reading of whole-body mri (wb-mri) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images procedures to be used: whole-body mri images risks and potential benefits: no additional risk (the infant will be receiving and mri of their brain as part of routine care, the additional images will be obtained at the same time without additional sedation); benefits to the infant include the identification of injuries which would have otherwise been missed by routine care importance of knowledge that may reasonably be expected to result: results from this study will potentially influence the use of radiographic skeletal survey and decrease the radiation exposure to infants being evaluated for suspected child abuse.


Eligibility criteria:
inclusion criteria: * younger than 12 months * admitted to the hospital * getting an mri for suspected abusive head trauma exclusion criteria: -